MAUDE Adverse Event Report: NALU MEDICAL INC NAUL NEUROSTIMULATION SYSTEM; SPINAL CORD STIMULATOR

Model Number 71004

Device Problem Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Date 03/03/2022

Event Type  Injury  

Event Description

Patient's device was explanted due to confirmed (b)(6) at midline incision.Incision site reported to have small opening where infection was detected.Patient has multiple comorbidities including lupus.

• Brand Name: NAUL NEUROSTIMULATION SYSTEM
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): NALU MEDICAL INC; 2320 faraday avenue; suite 100; carlsbad CA 92008 2377
• Manufacturer (Section G): NALU MEDICAL INC.; 2320 faraday avenue; suite 100; carlsbad CA 92008 7241
• Manufacturer Contact: terry villarba ; 2320 faraday avenue; suite 100; carlsbad, CA 92008-7241 ; 7604482360
• MDR Report Key: 13726796
• MDR Text Key: 287141073
• Report Number: 3015425075-2022-00010
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00812537033594
• UDI-Public: 01008125370335941121051117240511
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2024
• Device Model Number: 71004
• Device Catalogue Number: 71004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other